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Effect of Sago-based Product on Glycaemic and Lipid Control in Diabetes

NCT ID: NCT05599633

Last Updated: 2024-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-10

Study Completion Date

2024-01-20

Brief Summary

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This will be a parallel, randomised, double-blind, controlled trial. Upon successful screening, subjects will be randomised to either intervention arm or control arm in a ratio of 1:1. The subjects will consume either a drink containing 25g of Sarawak sago starch (intervention) or 25g of corn starch (control) in approximately 200mL of water, two times a day, before lunch and dinner for 12 weeks, in addition to a standardised dietary counselling for diabetes given by the hospital dietitian at baseline. The study endpoints will be evaluated after 12 weeks of starch consumption.

Detailed Description

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SAGODM trial is a parallel, randomised, double-blind, controlled trial on the effect of consuming sago starch for 12 weeks on glycaemic and lipid control in patients with type 2 diabetes mellitus. Diabetic patients who had HbA1C between 6.5% and 8.5% and had no change in the antidiabetic treatment for the past two months (primary inclusion criteria) were invited to participate in the trial. They were randomised to either the intervention arm or control arm in a ratio of 1:1. The subjects will consume either a drink containing 25g of Sarawak sago starch (intervention) or 25g of corn starch (control) in approximately 200mL of water, two times a day, before lunch and dinner for 12 weeks. They will receive standardised dietary counselling for diabetes given by the hospital dietitian at baseline. They will also be asked to record their dietary intake for three consecutive days every month. Blood samples will be taken at baseline and the last visit (post-12 weeks). The study endpoints will be evaluated after 12 weeks of starch consumption.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Intervention (Sago starch) and control (corn starch) will be packed in individual aluminium sachets and will not be distinguishable from each other. The included subjects and investigators will be blinded from the study arm assignment. Randomisation and dispensation of the study starch will be done by the unblinded pharmacists only, who will not be involved in the care of the patients and study endpoint assessments.

Study Groups

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Intervention Arm

Subjects who are randomised to Intervention Arm will be taking a drink containing 25g of Sarawak sago starch in 200mL of plain water. The subjects will take the drink twice daily i.e., within 30 minutes before lunch and dinner. On top of that, they will be counselled on diet recommendations for diabetes by a study dietitian at Visit 1 or baseline.

Group Type EXPERIMENTAL

Sago starch drink

Intervention Type DIETARY_SUPPLEMENT

Sarawak sago starch drink will be provided by CRAUN throughout the study. The starch drink will be supplied in sealed aluminium sachets. Each sachet contains 25g of study starch with cocoa flavouring.

Control Arm

Subjects who are randomised to Control Arm will be taking a drink containing 25g of corn starch in 200mL of water. The subjects will take the starch suspension twice daily i.e., within 30 minutes before lunch and dinner. On top of that, they will be counselled on diet recommendation for diabetes by a study dietitian at Visit 1 or baseline.

Group Type PLACEBO_COMPARATOR

Corn starch drink

Intervention Type DIETARY_SUPPLEMENT

Corn starch drink will be provided by CRAUN throughout the study. The starch drink will be supplied in sealed aluminium sachets. Each sachet contains 25g of study starch with cocoa flavouring.

Interventions

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Sago starch drink

Sarawak sago starch drink will be provided by CRAUN throughout the study. The starch drink will be supplied in sealed aluminium sachets. Each sachet contains 25g of study starch with cocoa flavouring.

Intervention Type DIETARY_SUPPLEMENT

Corn starch drink

Corn starch drink will be provided by CRAUN throughout the study. The starch drink will be supplied in sealed aluminium sachets. Each sachet contains 25g of study starch with cocoa flavouring.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. 18 - 70 years old
2. Individual diagnosed with type 2 diabetes for at least three months
3. Not on any antidiabetic medications or on lifestyle modification or taking a stable dose of oral hypoglycaemic agents, with no change of dose and regime for the past eight weeks
4. Has HbA1C values of 6.5 - 8.5% within 28 days before commencing the study
5. Able to complete the clinical study, and
6. Able to provide written informed consent

Exclusion Criteria

1. History of allergy to sago starch or corn starch
2. History of allergy to any other ingredients in the study foods
3. Clinically significant, active and acute cardiovascular disease
4. Clinically significant, stage 4 - 5 (estimated glomerular filtration rate \<30mL/min/1.73m2), chronic kidney failure
5. Clinically significant chronic liver disease or infection
6. Any malignancies
7. Regular use of hormone medications, anti-inflammatory medication, steroids, or other medications that might interfere with outcome measure
8. On a prescribed therapeutic diet
9. Taking part in weight loss programme
10. Clinically significant abnormal laboratory investigations
11. Other medical conditions or reasons, in the opinion of the Investigator or Research Physician, that make one unsuitable to join the study
12. Concurrent participation in other clinical studies involving intervention or treatment towards obesity, diabetes or impaired glucose
13. Pregnant or lactating mothers
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CRAUN Research Sdn. Bhd.

UNKNOWN

Sponsor Role collaborator

Sarawak General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xun Ting Tiong

Medical Officer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xun Ting Tiong

Role: PRINCIPAL_INVESTIGATOR

Clinical Research Centre Sarawak General Hospital

Locations

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Klinik Kesihatan Batu Kawah

Kuching, Sarawak, Malaysia

Site Status

Klinik Kesihatan Jalan Masjid

Kuching, Sarawak, Malaysia

Site Status

Klinik Kesihatan Tanah Puteh

Kuching, Sarawak, Malaysia

Site Status

Sarawak General Hospital

Kuching, Sarawak, Malaysia

Site Status

Countries

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Malaysia

References

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King TL, Bugam SH, Khoo SY, Tan SH, Yeo JJP, Tan SSN, Chan PY, Liew NK, Chunggat J, Tiong LL, Ibrahim AS, Tan FHS, Tiong XT. Effects of 12 Weeks consumption of sago starch on glycaemic and lipid control in patients with type 2 diabetes: A double-blind, randomised, parallel controlled trial. Clin Nutr ESPEN. 2025 Aug;68:300-308. doi: 10.1016/j.clnesp.2025.05.002. Epub 2025 May 8.

Reference Type DERIVED
PMID: 40345654 (View on PubMed)

Other Identifiers

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CRC003-SAGODM

Identifier Type: -

Identifier Source: org_study_id